Events

Safety Alert for CONTINUUM INFUSION SYSTEM, MIK codes 200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, 3015160 and 3015161. Anvisa Registry No. 80172890011.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Medrad do Brasil; Equip. Prod. Sáude e Serviços Técnicos Ltda.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1133
  • Date
    2012-05-16
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Extra notes in the data
    According to the record holder, the accuracy of the Continuous Infusion system is defined in the product specification contained in the operating manual (+/- 10% +/- 2C). Technical complaints received by the company claim sub-dose and root cause analysis determined variations in infusion characteristics attributed to variation in elasticity property and resistance of the connectors, which can directly affect system performance. Tests performed indicate that the connector exhibits a higher glass transition temperature and is significantly more rigid at room temperature, resulting in a material having an undesirable elastic property and which, when used as part of an infusion mechanism, exhibits significant variation relative to the flow rate accuracy (outside the accuracy limit of +/- 10%). A risk study was conducted by the company to evaluate technical complaints and there are two risk scenarios associated with this situation: Scenario 1: The operator realizes that the patient is not receiving the volume and flow rate programmed during or after the procedure. The completion of this risk assessment has an unacceptable level of safety; Scenario 2: The Biomedical engineer examines the accuracy of the pump before performing the procedure and based on the error presented the procedure is not performed. The completion of this scenario is within acceptable security level. For additional information, consult the alert message issued by the company at http://portal.anvisa.gov.br/wps/wcm/connect/5459c9004b44c2949a6e9aaf8fded4db/Alerta_1133_Apenta_Messagem.pdf?MOD=AJPERES.
  • Reason
    The equipment may be infusing a smaller than expected volume (sub-dose).
  • Action
    Users are required to segregate the device, fill out a form stating the quantity of affected products in their inventory, send a communication letter (with completed form) to the registration holder and make the affected products available for withdrawal at the institution by the registration holder. The forms for communication to the company are available at http://portal.anvisa.gov.br/wps/wcm/connect/112c44004b44c2ee9a779aaf8fded4db/Alerta_1133_Formul%C3%A1rios.pdf?MOD=AJPERES.

Device

CONTINUUM INFUSION SYSTEM, MIK codes 200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158,...

Manufacturer

Medrad do Brasil; Equip. Prod. Sáude e Serviços Técnicos Ltda
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    ANVSANVISA